FDA Clearance


  • June 2014 – HairMax received FDA Clearance of the HairMax® LaserBand for the treatment of androgenetic alopecia* (pattern hair loss) in both men and women.
  • June 2011 – HairMax received FDA two Clearances for the treatment of hair loss in females with androgenetic alopecia* with different models
  • January 2009 – HairMax received FDA clearance for design changes
  • January 2007 – The HairMax LaserComb® became the first and only medical laser device for home use to receive FDA Clearance for the treatment of hair loss in males with androgenetic alopecia*(pattern baldness).

From our inception in 2000, we have dedicated ourselves to make Low Level Laser Treatments available for treating hair loss at home. We embarked on an extensive research program designed to receive FDA Clearances as medical devices, not simply cosmetic ones. HairMax® devices are clinically proven to actually regrow hair.

In 2007, after years of research, development and substantial investment, a historic event took place, HairMax was granted the first ever FDA clearance as a laser phototherapy device for home use to treat hair loss and promote of hair growth*. We didn’t stop with just one FDA Clearance, HairMax Laser devices have been granted an unprecedented total of 7 FDA Clearances to date. No other Laser phototherapy device on the market has anywhere near this number FDA Clearances.

You can be sure that HairMax laser devices are of the highest quality, with the most proof of consistent and predictable efficacy than any other device on the market. HairMax leads and never follows, from FDA Clearances to Clinical Studies to the variety of laser device models available, we are the world wide leaders in home use laser hair technology.

HairMax: The Pioneers of At- Home Low Level Laser Hair Loss Treatments

HairMax pioneered at home laser phototherapy treatment for hereditary hair loss. HairMax Laser devices have revolutionized the way men and women around the world treat their hair loss. Prior to HairMax, treatment options were limited to oral and topical drugs. There were only two drugs, Propecia®/finasteride and Rogaine® 5%/minoxidil approved for treating hair loss in males, and only one drug, Rogaine® 2%/minoxidil available to women.

With HairMax laser devices a safe and effective, non-drug, non-topical treatment option is available. In fact, a peer review medical journal article published by leading authorities in the field of hair loss compared the clinical results of HairMax Laser treatments with clinical results of minoxidil and Propecia and found them to be comparable. Of utmost importance, HairMax Laser devices have an excellent safety record, with no harmful side effects ever reported.

HairMax Hair Loss Treatment FDA Clearance

In 2006, after years of extensive research and randomized clinical studies, Lexington International submitted the results of its initial six-month, multi-center placebo controlled clinical trial to the FDA. The data from the trial demonstrated that 93% of the male subjects had highly statistical improvement in hair counts after 26 weeks of treatment.

Based on part of the results of this study, the FDA granted initial marketing clearance for the treatment of androgenetic alopecia, (pattern hair loss)* and promotion of hair growth in males in 2007. In 2011, additional clinical studies by HairMax were submitted to the FDA and clearance was granted for females with androgenetic alopecia, (pattern hair loss)*. To date, close to a million people around the world have chosen to use the HairMax Laser devices to treat their hair loss and enrich their lives.


HairMax Laser devices FDA 510(k) Clearances as Medical Devices Are Based Not Only On Safety But Also On The Submission Of Proof of Efficacy.

There have now been a total of 7 FDA Clearances of HairMax Laser devices for marketing, all of which required the submission of not only safety, but also effectiveness based on scientifically designed clinical research studies.

These submissions and all of our FDA Clearances, means that all data submitted was subject to intense scrutiny and review. When a company receives FDA Clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control.

To put it simply, we know there are countless products on the market that promise to re-grow hair, but end up having little or no effectiveness. You can trust HairMax to treat your hair loss, because of the extensive clinical research conducted which proves the efficacy and safety of HairMax devices. Our clinical studies results have been conducted by top physicians in the field of hair loss and study results have been published in 6 peer review medical journals, this makes HairMax the only laser devices for hair loss on the market with such unsurpassed substantial validation.